Product Quality Clinician

Innovation starts from the heart. Edwards Lifesciences   is the leading global structural heart innovation company, driven by a passion to improve patient lives.   With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Product Quality Clinician position is a unique career opportunity that could be your next step towards an exciting future.   How you will make an Impact: Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks. Provide clinical expert knowledge, clinical data insights and risk evaluation guidance to Quality Specialists to support complaint assessment, trend identification, regulatory decision-making and potential health risk evaluation within Structural Heart therapies. Analyze and interpret aggregate complaint, clinical and post-market data for a specific product line, business unit, regulatory submissions, regulatory agency requests and management reports, including trend identification, visualization and ad hoc analytical summaries.   Provide clinical input to Product Risk Assessments (PRA), utilizing complaint data, clinical trends and predictive risk indicators where appropriate.   Support the development and use of AI-enabled tools to enhance complaint evaluation, signal detection and quality decision-making.   Review and interpret relevant imaging information in support of complaint investigations, product quality assessments and risk evaluations.   Develop data visualization tools and dashboards to support quality monitoring, trend detection and management decision-making.   Support Product Safety in development of clinically based training materials and educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks.   Provide medical/clinical guidance and final direction to complaint staff related to event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. May review complaint conclusions/closure statements and/or customer letters.   May provide training to complaint staff on patient anatomy and medical conditions, products and procedures, and internal policies and procedures.   Provide support in complaint data and relevant clinical information for regulatory submissions or regulatory agency requests.   Mentor, coach, and provide training for other Clinicians Quality Compliance and Quality Specialists.   Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution.   Support Product Safety to maintain Decision Rationale Matrix to guide complaint staff and provide final direction on reporting decisions.

(Required): Bachelor's Degree or Equivalent in related field 5-7 years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (i.e. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) What else we look for (Preferred): Use of AI-enabled tools Data visualization & analysis Excellent facilitation, presentation, and public speaking skills Proven successful project management skills Previous experience working in a large manufacturing company Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System) Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives Recognized as an expert in own area with specialized depth within the organization Expert understanding of International Quality System Regulations Working knowledge of Medical Device regulations, and